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HRD-83-52 1 (1983-09-26)

handle is hein.gao/gaobabegg0001 and id is 1 raw text is: ESTPHCTE --0 t90 s eiicapdvl BY T E MPTROLLER GENERA~z--L Report To The Honorable Paula Hawkins United States Senate OF THE UNITED STATES Improvements Needed In Clinical Testing Of Anticancer Drugs Despite improvements in the way the Food and Drug Administration (FDA) and the National Cancer Institute (NCI) have carried out their responsibilities of protecting patients during clinical testing of anticancer drugs, further improvements should be made. Actions needed by FDA include (1) more promptly notifying sponsors of clinical drug tests of concerns raised during its review of study proposals, (2) establishing a followup system to assure that its concerns are addressed by sponsors, (3) requiring sponsors to submit all study plans (protocols) before clinical testing begins, (4) clarifying its requirements for the reporting of adverse drug reactions, and (5) issuing final regulations specifying the monitoring responsibilities of sponsors. Actions needed by NCI include (1) advising FDA in a timely manner of actions taken or to be taken on concerns raised by FDA, (2) requiring that site monitoring visits be made frequently enough to assure that the studies are properly carried out, and (3) studying the need for and usefulness of its drug study data system and, if needed, requiring that data be submitted in a more timely and complete manner. 'FD S7?W 0 GAO/HRD-83-52 SEPTEMBER 26, 1983 4 E RELEASED LM122524

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